An earthquake struck the area where I grew up last week and again this weekend in southern Illinois. Shocking. But it wasn’t the first earthquake of the week. Aftershocks continue.
The JAMA report last week measured very high on the Richter scale to shake up reputations and public faith and perception in the pharmaceutical industry. Even more shocking. And many more aftershocks are likely.
The report – "Guest Authorship and Ghostwriting in Publications Related to Rofecoxib" set out to identify the extent of ghostwriting – writing articles and then regarding Vioxx. It is illuminating and it has consequences not only for the company involved but for each member of the industry. Trust, on the part of th public and policymakers, is eroding even further, at least my gut tells me so. And, as I’ve been writing about the expected scope of FDA and pharma reforms a lot lately, this is another area to add to the growing list.
That is evidenced just this weekend in The New York Times that reported that as a consequence of the news about the ghostwriting, the FDA plans to relax standards of off-label promotion by firms may now be in jeopardy. The ghostwriting issue may be focused on Merck in the report, but it is the entire industry that is painted with the broad brushstroke.
The report raises questions about the integrity not only of the Vioxx study publications, and of Merck, but also of the entire industry. Study publications in peer reviewed journals are a bedrock of our faith and understanding of the safety, efficacy and use of products. It would, therefore, not be surprising to see some kind of reform introduced that would hold companies to a standard for authorship and perhaps charge the journals with an official duty to ensure that the articles they publish were indeed written by the people who are represented as authors. It is called fact checking.
